Quality Certifications, Management System & Regulator Requirements - HairMax Australia
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on Laser Devices

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on Laser Devices

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AU : 61 (07) 3198 2484

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Quality Certifications - Old

Confidence Through Efficacy, Quality & Certification

Lexington International LLC. is dedicated to providing products that consistently meet or exceed the requirements and expectations of our customers. The application of a rigorous Quality Management System, including a commitment to comply with regulatory requirements ensures the highest possible environmental and safety standards.

hairmax laser diode inspection

Final laser diode validation and inspection

Hairmax laser diode fabrication

Automated laser diode fabrication

hairmax laserband 82 distribution

Pallet of LaserBand 82

Hairmax Laserband 82 glow

LaserBand 82 laser diodes


All manufacturing processes are state-of-the-art and ISO Quality Assured.

ISO 13485:2016 – Quality System Certification
MDSAP Certified Company
USFDA Good Manufacturing Practices (GMP) – We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations
Europe * Emergo Europe, 2514 AP The Hague, Netherlands. http://www.EmergoGroup.com

The HairMax Laser Devices maintain ISO 13485:2016 certification and is audited by:
InterTek Testing Services
70 Codman Hill Road
Boxbourough, MA 01719 USA
Telephone: 1 (978) 929-2100

MDSAP and ISO 13485:2016
(Certificate of Registration)

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